Opioid-use DisorderCTN-0096NCT04958798
Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska Native Communities
A study testing Culturally Centered MOUD Implementation Intervention in people with Opioid-use Disorder, run by New York State Psychiatric Institute at 3 sites in United States.
Trial summary
This is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder in four healthcare and addiction specialty treatment sites serving American Indian and Alaska Native communities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Culturally Centered MOUD Implementation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,059 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Dec 2021to 16 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving services at a participating study site
- Meet criteria for a current opioid use disorder
- Identify as American Indian or Alaska Native
- 18 years or older
Who cannot join
- Not Applicable
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Southcentral Foundation
Anchorage, Alaska, 99508
Missouri Breaks
Eagle Butte, South Dakota, 57625
Native American Community Clinic
Minneapolis, Minnesota, 55404
About this study
Official title: Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska
This is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder in four healthcare and addiction specialty treatment sites serving American Indian and Alaska Native communities.
Read the detailed description
This is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder (MOUD) in four healthcare and addiction specialty treatment sites serving American Indian and Alaska Native communities. The study design is a cluster randomized stepped wedge implementation trial with two steps, and two sites per step (N=4 sites). Study design and methods are informed by the Consolidated Framework for Implementation Research (CFIR) and the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). The primary outcome of the trial is the number of consumers with OUD initiated onto MOUD (i.e., buprenorphine, extended-release naltrexone, or methadone) in the 6 months after intervention delivery (compared to the 6 months before intervention delivery) - capturing implementation intervention Reach. The primary outcome will be measured at the end of the six-month implementation stage and compared to the pre-intervention observation phase (prior to delivery of the implementation intervention). Primary data collection will use de-identified data from the electronic medical records (EMR) at each site beginning with data from the six months prior to intervention delivery for Step 1 sites and 12 months prior for Step 2 sites. For Step 1 sites, some secondary outcomes will also be assessed during the sustainment stage (the six months following implementation) but this will be exploratory. As part of the study, consumers with OUD will be asked to participate in additional assessments and provide informed consent. Enrolled consumer participants will be asked to complete four assessment visits (baseline, week 4, week 8, and week 12) to collect comprehensive information about mental health, cultural connectedness and spirituality, social functioning, and experiences with and acceptability of OUD treatment. Providers at each clinical site will also be asked to complete surveys at three time points to assess attitudes, knowledge, and readiness related to MOUD.
- Conditions
- Opioid-use Disorder
- Being tested
- Culturally Centered MOUD Implementation Intervention
- Keywords
- American Indian, Alaska Native, Medications for Opioid-use Disorder, Implementation, Cultural centering
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Centered MOUD Implementation InterventionBehavioural
Support clinical sites to culturally center the delivery of medications for opioid use disorder through evidence-based implementation strategies tailored to local needs
| Study group | Role | What they receive |
|---|---|---|
| Culturally Centering MOUD Program Implementation Intervention | Experimental | Culturally centered program-level implementation intervention to increase the use of medications for opioid use disorder in healthcare and treatment settings serving AI/AN communities. Receives: Behavioral: Culturally Centered MOUD Implementation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Consumers With OUD Initiated Onto MOUD
The primary outcome is comprised of de-identified EMR data comparing MOUD initiation pre-intervention to post-intervention time periods with offset terms for time and clinic size.
Measured: Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)
Secondary outcomes (2)
Number of Consumers With OUD Retained in Care
Retention is operationalized as the number of clients at each site during each period who had at least one visit for care in three or more months within that period using de-identified data from the EMR comparing pre-intervention to post-intervention time periods.
Measured: Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)
Number of Consumers Screened for OUD
Screening was operationalized as the number of clients screened for OUD of the number of clients with documented OUD and a visit from the de-identified EMR comparing pre-intervention to post-intervention time periods.
Measured: Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start20 Dec 2021
- Primary completion13 Dec 2024
- Study completion16 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- All sites (N=4) started in standard/usual care and then were randomly assigned to receive the program level implementation intervention in sequence 1 (2 sites) or sequence 2 (2 sites).
- Masking
- None (open label)
- Enrolment
- 2,059 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico
- Responsible party
- Principal investigator, Aimee Campbell, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958798
- Sponsor's protocol ID
- #8026
- Acronym
- CTN-0096
- Status last verified
- May 2026
- First submitted
- 6 Jul 2021
- Last updated
- 11 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data from this study is owned by participating Tribal clinical sites; any use of IPD requires Tribal (or equivalent organizational) approval.
Publications
Paschen-Wolff MM, Campbell ANC, Vasquez A, Kessler J, Jansen K, Arnatt CP, Rosa C, Hebden HM, Radin S, Stately A, Shaw J, Kennedy F, Matthews AG, Venner KL. Conducting an implementation intervention study with American Indian and Alaska Native communities: Methodological considerations. Contemp Clin Trials. 2025 Aug;155:107992. doi: 10.1016/j.cct.2025.107992. Epub 2025 Jun 20.
PubMed 40544955Hirchak KA, Nadeau M, Vasquez A, Hernandez-Vallant A, Smith K, Pham C, Oliver KA, Baukol P, Lizzy K, Shaffer R, Herron J, Campbell ANC, Venner KL; CTN-0096 Collaborative Board. Centering culture in the treatment of opioid use disorder with American Indian and Alaska Native Communities: Contributions from a National Collaborative Board. Am J Community Psychol. 2023 Mar;71(1-2):174-183. doi: 10.1002/ajcp.12620. Epub 2022 Aug 23.
PubMed 35997562
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska
- ClinicalTrials.gov ID
- NCT04958798
- Acronym / sponsor ID
- CTN-0096 / #8026
- Conditions
- Opioid-use Disorder
- Keywords
- American Indian, Alaska Native, Medications for Opioid-use Disorder, Implementation, Cultural centering
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,059 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- University of New Mexico
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 16 Jan 2025 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Posted 11 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder in four healthcare and addiction specialty treatment sites serving American Indian and Alaska Native communities.
Detailed description
This is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder (MOUD) in four healthcare and addiction specialty treatment sites serving American Indian and Alaska Native communities. The study design is a cluster randomized stepped wedge implementation trial with two steps, and two sites per step (N=4 sites). Study design and methods are informed by the Consolidated Framework for Implementation Research (CFIR) and the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). The primary outcome of the trial is the number of consumers with OUD initiated onto MOUD (i.e., buprenorphine, extended-release naltrexone, or methadone) in the 6 months after intervention delivery (compared to the 6 months before intervention delivery) - capturing implementation intervention Reach. The primary outcome will be measured at the end of the six-month implementation stage and compared to the pre-intervention observation phase (prior to delivery of the implementation intervention). Primary data collection will use de-identified data from the electronic medical records (EMR) at each site beginning with data from the six months prior to intervention delivery for Step 1 sites and 12 months prior for Step 2 sites. For Step 1 sites, some secondary outcomes will also be assessed during the sustainment stage (the six months following implementation) but this will be exploratory. As part of the study, consumers with OUD will be asked to participate in additional assessments and provide informed consent. Enrolled consumer participants will be asked to complete four assessment visits (baseline, week 4, week 8, and week 12) to collect comprehensive information about mental health, cultural connectedness and spirituality, social functioning, and experiences with and acceptability of OUD treatment. Providers at each clinical site will also be asked to complete surveys at three time points to assess attitudes, knowledge, and readiness related to MOUD.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All sites (N=4) started in standard/usual care and then were randomly assigned to receive the program level implementation intervention in sequence 1 (2 sites) or sequence 2 (2 sites).
| Arm | Type | Receives |
|---|---|---|
| Culturally Centering MOUD Program Implementation Intervention | Experimental | Behavioral: Culturally Centered MOUD Implementation InterventionCulturally centered program-level implementation intervention to increase the use of medications for opioid use disorder in healthcare and treatment settings serving AI/AN communities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Receiving services at a participating study site
- Meet criteria for a current opioid use disorder
- Identify as American Indian or Alaska Native
- 18 years or older
Key exclusion criteria (1 listed)
- Not Applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally Centered MOUD Implementation InterventionSupport clinical sites to culturally center the delivery of medications for opioid use disorder through evidence-based implementation strategies tailored to local needs | Behavioural | Culturally Centering MOUD Program Implementation Intervention |
Primary outcome
Number of Consumers With OUD Initiated Onto MOUD
Time frame: Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)
The primary outcome is comprised of de-identified EMR data comparing MOUD initiation pre-intervention to post-intervention time periods with offset terms for time and clinic size.
2 secondary outcomes
Number of Consumers With OUD Retained in Care
Time frame: Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)
Number of Consumers Screened for OUD
Time frame: Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 40544955Paschen-Wolff MM, Campbell ANC, Vasquez A, Kessler J, Jansen K, Arnatt CP, Rosa C, Hebden HM, Radin S, Stately A, Shaw J, Kennedy F, Matthews AG, Venner KL. Conducting an implementation intervention study with American Indian and Alaska Native communities: Methodological considerations. Contemp Clin Trials. 2025 Aug;155:107992. doi: 10.1016/j.cct.2025.107992. Epub 2025 Jun 20.
- Background: PubMed 35997562Hirchak KA, Nadeau M, Vasquez A, Hernandez-Vallant A, Smith K, Pham C, Oliver KA, Baukol P, Lizzy K, Shaffer R, Herron J, Campbell ANC, Venner KL; CTN-0096 Collaborative Board. Centering culture in the treatment of opioid use disorder with American Indian and Alaska Native Communities: Contributions from a National Collaborative Board. Am J Community Psychol. 2023 Mar;71(1-2):174-183. doi: 10.1002/ajcp.12620. Epub 2022 Aug 23.
- Individual participant dataSharing planned: No. Data from this study is owned by participating Tribal clinical sites; any use of IPD requires Tribal (or equivalent organizational) approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Centered MOUD Implementation Intervention in people with Opioid-use Disorder, run by New York State Psychiatric Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Consumers With OUD Initiated Onto MOUD (time frame: Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04958798, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.